Impact of Computer-Aided Detection (CAD) as Second Reader in CT Colonography

NCT01399710 | Completed Phase 3 DMC

• 1 other identifier: CAD COLON 001
• Study Type: interventional
• Target: 651
• Locations: 0 countries
• Sites: N/A

Brief Summary

RATIONALE: CT colonography accurately detects large polyps and masses. However, the test is less accurate in identifying lesions between 6 and 9 mm.Use of computer-aided detection (CAD) has shown promising results in providing uniform accuracy and improving CT colonography sensitivity. PURPOSE:This clinical trial compared the performance of CT colonography with unassisted and CAD-assisted reading in detecting patients with colorectal lesions.

Conditions

Individuals With Suspected Colorectal Disease

Keywords

colorectal cancer; CT colonography; CAD

Outcome Measures

Primary Outcomes (2)

• Sensitivity of CT colonography with unassisted and CAD-assisted reading in detecting individuals with lesions 6 to 9 mm

• Specificity of CT colonography with unassisted and CAD-assisted reading in detecting individuals with no clinical relevant lesions

Secondary Outcomes (2)

• Sensitivity of CT colonography with unassisted and CAD-assisted reading in detecting individuals with lesions 10 mm or larger

• Sensitivity of CT colonography with unassisted and CAD-assisted reading in detecting lesions 6 mm or larger

Interventions

CT colonography PROCEDURE

Participants were placed on a CT table and a small flexible rectal catheter was positioned. N-butyl-scopolamine was administered intravenously if this was common practice in the participating center. Immediately before scanning, pneumocolon was obtained through insufflation of room air or carbon dioxide, either manually by means of a balloon pump or with an automatic device, until maximum tolerance was reached. CT colonography was performed with the participant in supine and prone positions with the following scanning protocol: 120 kilovolt peak (kVp), 50 or fewer effective mA per second, and a section thickness not greater than 1.25 mm.

colonoscopy PROCEDURE

Colonoscopy was performed at least 3 hours after CT colonography. The endoscope was advanced to the cecum and the entire length of the bowel was examined during endoscope withdrawal. The endoscopist was initially blinded to the result of CT colonography; at the end of each bowel segment evaluation, CT colonography results for that segment were disclosed (segmental unblinding). If a lesion measuring 6 mm or larger was detected at CT colonography but not at colonoscopy, the segment was reexamined to resolve the discrepancy

CT Colonography with computer assisted diagnosis (CAD),CADCOLON -im3D SpA., Torino Italy DEVICE

Each CT colonography study was read in two phases. In the first phase the radiologist interpreted the examination without activating the CAD algorithm. This phase of reporting was defined as unassisted reading. Then the radiologist activated the CAD algorithm which pinpointed a series of colorectal lesion-like structures (i.e. lesion candidates) on both the prone and supine acquisition. All lesion candidates were examined. The second phase of reporting was defined as CAD-assisted reading.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- clinical indication to undergo colonoscopy either for symptoms, or participating a surveillance program or a CRC screening

You may not qualify if:

• clinical diagnosis of familial adenomatous polyposis or hereditary nonpolyposis CRC syndrome
• inflammatory bowel disease
• celiac disease
• evidence of increased risk of harm from colonoscopy
• psychological or physical conditions that contraindicated colonoscopy or CT Colonography

Sponsors & Collaborators

• im3D S.p.A.: lead
• Candiolo Cancer Institute - IRCCS: collaborator
• Bicocca Universiy of Milano, Milan, Italy: collaborator
• Fondazione Salvatore Maugeri: collaborator
• Catholic University, Italy: collaborator
• Valduce Hospital: collaborator
• University of Turin, Italy: collaborator
• University of Roma La Sapienza: collaborator
• IRCCS Azienda Ospedaliero-Universitaria di Bologna: collaborator
• Nuovo Regina Margherita Hospital: collaborator
• University of Pisa: collaborator
• University of Florence: collaborator
• IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy: collaborator

Related Publications (1)

• Regge D, Della Monica P, Galatola G, Laudi C, Zambon A, Correale L, Asnaghi R, Barbaro B, Borghi C, Campanella D, Cassinis MC, Ferrari R, Ferraris A, Hassan C, Golfieri R, Iafrate F, Iussich G, Laghi A, Massara R, Neri E, Sali L, Venturini S, Gandini G. Efficacy of computer-aided detection as a second reader for 6-9-mm lesions at CT colonography: multicenter prospective trial. Radiology. 2013 Jan;266(1):168-76. doi: 10.1148/radiol.12120376. Epub 2012 Nov 14.

  PMID: 23151831 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Colonoscopy; Colonography, Computed Tomographic; Diagnosis, Computer-Assisted

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Tomography, X-Ray Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray

Study Officials

• Daniele Regge

  Institute Institute for Cancer Research and Treatment, Candiolo, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 15, 2011
• First Posted: July 22, 2011
• Study Start: July 1, 2007
• Primary Completion: May 1, 2009
• Study Completion: March 1, 2010
• Last Updated: July 22, 2011

Record last verified: 2011-07